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FDA updates Nuvation Bio's IBTROZI label with 49.7-month response data

Thu, 17 Sep 2026 07:30:29 -0400

Nuvation Bio Inc. (NYSE: NUVB) announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application for IBTROZI (taletrectinib), updating the drug's label to include a median duration of response of 49.7 months in TKI-naïve patients from the TRUST-I study.

The approval, which came four months ahead of the scheduled PDUFA date, incorporates data from an August 2025 cutoff reflecting a median follow-up of 51 months for TRUST-I patients. The updated label includes an additional 14 months of data from both the TRUST-I and TRUST-II pivotal studies. The company stated no changes were made to the safety sections

Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer

Thu, 17 Sep 2026 07:30:00 -0400

Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months

No changes to the safety sections of labeling with longer follow-up and no new safety signals identified

Approval comes four months ahead of PDUFA date

Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer

Thu, 17 Sep 2026 07:30:00 -0400

Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months

No changes to the safety sections of labeling with longer follow-up and no new safety signals identified

Approval comes four months ahead of PDUFA date

Nuvation Bio (NUVB) Reiterated at Market Outperform by Citizens on ROS1 TKI Competitive Profile

Wed, 16 Sep 2026 05:40:25 -0400

Citizens analyst Silvan Turkcan reiterated a Market Outperform rating and $10.00 price target on Nuvation Bio Inc (NYSE: NUVB).

The analyst commented, "At the World Conference on Lung Cancer, clinical updates for Nuvalent/GlaxoSmithKline's (NUVL/GSK) ROS1 TKI, zidesamtinib, demonstrated a competitive profile in the TKI-naïve setting, but immaturity of the dataset and the two-year head start for NUVB's IBTROZI – which we still view as best-in-class, represent a large hill to climb for the potential newcomer. We maintain our Market Outperform rating and $10 DCF-derived price target for NUVB as we continue to monitor the launch."

For an analyst ratings summary and ratings

Nuvation Bio presents Ibtrozi subgroup data at lung cancer conference

Tue, 15 Sep 2026 08:01:44 -0400

Nuvation Bio Inc. (NYSE: NUVB) presented new subgroup analyses of its cancer drug Ibtrozi (taletrectinib) at the IASLC 2026 World Conference on Lung Cancer in Seoul, South Korea, on Sept. 15, showing consistent efficacy across patient groups with advanced ROS1-positive non-small cell lung cancer (NSCLC).

The analyses, drawn from the pooled TRUST-I and TRUST-II studies, examined outcomes based on prior chemotherapy exposure and ROS1 fusion partner type. Among TKI-naïve patients, the objective response rate (ORR) was 90.0% in those with prior chemotherapy and 89.8% in those without. Median duration of response (DOR) was 48.3 months and 54.3 months, respectively.

Across fusion-partner subgroups,

Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Canc

Tue, 15 Sep 2026 08:00:00 -0400

Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups

Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified

Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Canc

Tue, 15 Sep 2026 08:00:00 -0400

Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified

Nuvation Bio to Participate in Upcoming Investor Conferences

Wed, 02 Sep 2026 16:05:00 -0400

NEW YORK, Sept. 2, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in fireside chats and one-on-one meetings at the following conferences:

Nuvation Bio to Participate in Upcoming Investor Conferences

Wed, 02 Sep 2026 16:05:00 -0400

Form 4 Nuvation Bio Inc. For: Aug 19 Filed by: Hattersley Gary

Fri, 21 Aug 2026 16:50:00 -0400

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Form 4 Nuvation Bio Inc. For: Aug 19 Filed by: Hattersley Gary

Fri, 21 Aug 2026 16:50:00 -0400

si-local-file:///var/storage/secattach/20260821/26962072.html

Cantor Fitzgerald Starts Nuvation Bio Inc (NUVB) at Overweight

Fri, 21 Aug 2026 06:05:35 -0400

(Updated - August 21, 2026 6:05 AM EDT)

Cantor Fitzgerald analyst Li Watsek initiates coverage on Nuvation Bio Inc (NYSE: NUVB) with a Overweight rating.

The analyst comments "We initiate coverage of Nuvation Bio (NUVB) at Overweight. Nuvation is a low-risk, high-reward commercial-stage oncology story built on two best-in-class targeted therapies. We believe the Street materially undervalues the size of both markets, driven in part by multi-year treatment duration. Ibtrozi (taletrectinib), a next-generation ROS1 inhibitor launched in 2025, provides the valuation floor. We believe growing 1L use in ROS1+ NSCLC (non-small cell lung cancer) and a multi-year duration of therapy should drive

Cantor Fitzgerald Starts Nuvation Bio Inc (NUVB) at Overweight

Fri, 21 Aug 2026 06:05:35 -0400

(Updated - August 21, 2026 6:05 AM EDT)

Cantor Fitzgerald analyst Li Watsek initiates coverage on Nuvation Bio Inc (NYSE: NUVB) with a Overweight rating.

FDA grants Nuvation Bio fast track status for brain cancer drug

Thu, 20 Aug 2026 08:00:31 -0400

Nuvation Bio Inc. (NYSE: NUVB) announced that the U.S. Food and Drug Administration has granted Fast Track Designation to safusidenib, the company's investigational oral drug candidate for the treatment of IDH1-mutant glioma.

The designation, granted in August 2026, is intended to facilitate development and expedite the review of drugs that treat serious conditions with unmet medical need. It allows for more frequent FDA interactions during development and, if relevant criteria are met, may permit rolling review of a marketing application.

The FDA's decision was based on clinical data from Nuvation Bio's safusidenib program. In the Phase 2 J201 study, at a median

FDA grants Nuvation Bio fast track status for brain cancer drug

Thu, 20 Aug 2026 08:00:31 -0400

The FDA's decision was based on clinical data from Nuvation Bio's safusidenib program. In the Phase 2 J201 study, at a median

FDA grants Nuvation Bio fast track status for brain cancer drug

Thu, 20 Aug 2026 08:00:31 -0400

The FDA's decision was based on clinical data from Nuvation Bio's safusidenib program. In the Phase 2 J201 study, at a median

FDA grants Nuvation Bio fast track status for brain cancer drug

Thu, 20 Aug 2026 08:00:31 -0400

The FDA's decision was based on clinical data from Nuvation Bio's safusidenib program. In the Phase 2 J201 study, at a median

Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

Thu, 20 Aug 2026 08:00:00 -0400

Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma